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NCT Number: NCT02745457

Body Composition in Children With Inflammatory Bowel Disease

Background: Growth impairment is commonly seen in children diagnosed with inflammatory bowel diseases (IBD), mainly those with Crohn's disease (CD). There is general consensus in the literature that body composition, composed of fat mass and lean mass is altered in children with IBD compared with controls. Evidence regarding the effect of different therapeutic approaches on body composition in children with IBD is scarce and inconsistent. Furthermore, most studies used anthropometric measures and dual energy X-ray absorptiometry (DEXA) for body composition assessment, while information on the usefulness of air displacement plethysmography (ADP) for this assessment is lacking.

Objectives: To assess body composition in children with IBD by ADP and DEXA at diagnosis and at various intervals during follow up.

Design: A prospective cohort study. Setting: Pediatric gastroenterology institute, Schneider Children's Hospital.

Participants: Children 6 year to 17 years who are diagnosed with either CD or ulcerative colitis (UC).

Main outcome measures: Accuracy of ADP in comparison to DEXA and percentage of fat mass and lean mass at diagnosis and during treatment.

Secondary outcome measures: Correlation of body composition to skin fold, mid arm circumference measurements, BMI, inflammatory markers, gender, disease activity and physical activity.

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Key information

Conditions

Crohn's Disease Colitis Colitis, Ulcerative Colonic Diseases Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases Ulcerative Colitis

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Schenider Children's Medical Center

Petah Tikva, 4920235, Israel

About this study

Children diagnosed with either Crohn's disease (CD) or Ulcerative Colitis (UC) under follow-up at the Pediatric gastroenterology institute, Schneider Children's Hospital, will be enrolled. Patients can be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment all patients will perform body composition assessment by air displacement plethysmography (ADP) and DEXA (no greater than 7 days between the 2 methods of measurement). At one and two years following initial assessment ADP measurement will be repeated, mid arm circumference and skin fold measurements will be taken and the patient will fill a physical activity questionnaire. Disease activity score (either Pediatric Crohn's Disease Activity Index for CD or Pediatric Ulcerative Colitis Activity Index for UC) will be calculated. Similar evaluation will be performed prior and immediately following exclusive enteral nutrition or corticosteroid courses and prior to any biologic therapy initiation.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of IBD
  • Age: 6 - 17 years ( inclusive)
  • Informed consent

Exclusion criteria

  • Pregnancy
  • Non IBD associated chronic diseases
  • Morbid obesity

Treatment and study plan

Primary outcomes

  1. To evaluate the change in body composition accorging to treatment treatment is children with IBD over the course of 2 years

    Time frame: 24 months

    Percentage of fat mass and lean mass at diagnosis and during treatment

Secondary outcomes

  1. To assess the accuracy of ADP in comparison to DEXA based measurement of body composition in children with IBD

    Time frame: 24 months

    To assess the validity of ADP in children with IBD using DEXA as a gold standard for body composition

  2. To evaluate the correlation of body composition to skin fold and mid arm circumference measurements in children with IBD

    Time frame: 24 months

  3. To evaluate the correlation of body composition with BMI

    Time frame: 24 months

  4. To evaluate the correlation of body composition with disease activity

    Time frame: 24 months

  5. To evaluate the correlation of body composition with physical activity

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Schneider Children's Medical Center, Israel

Other

Registry information

Official study title

The Natural Course and the Effect of Treatment on Body Composition in Children With Inflammatory Bowel Disease

Important dates

Study start
2016
Primary completion
2021
Study completion
2023
First posted
Apr 20, 2016
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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